Wireless technology and medical devices: the rules of the harmonized legislation

Wireless technology is the use of means of communication between electronic devices without using cables, among them we can mention the so-called computing devices "wireless", such as portable radio transmitters, pagers, cell phones, and RFID (Radio Frequency IDentification, but also Wife, GSM, GPRS) ubiquitous in everyday life and even in hospitals. In this case the use is intended to improve patient care (through devices for rapid access and exchange of diagnostic information, for example, and those relating to health care).

In addition to the undeniable benefits that are mainly found in this area, it is also useful to know the risks that the use of such technology entails, in the case of interference with medical devices, meaning "any instrument, apparatus, appliance, material or other product, whether used alone or in combination (including the software necessary for the proper functioning), intended by the manufacturer to be used in humans for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, (...) also with the purpose of investigation, replacement or modification of the anatomy or a physiological process of conception of the product which does not achieve its principal action in or on the human body that is targeted by pharmacological, immunological or by process metabolic function but which may be assisted by such means. " Among the various risks that the most important is the electromagnetic interference. That is why it is interesting to know the legal framework concerning the electromagnetic compatibility of medical devices, specifically for the purposes of control, excluding any type of anomaly, the potential dangers.

Under certain provisions of Community legislation defining the "essential requirements" which must have medical equipment to be placed on the European market and, consequently, the European reference are required to produce technical specifications indicated in the cod standards that define the essential minimum requirements which must match the quality of a medical device, according to CEI EN 60601-1-2: 2007. This does not differ at all from the international standard of the International Electro technical Commission (IEC) 60601-1-2 - which is established by the Food and Drug Administration, Agency for Food and Drugs, which deals with the regulation of food and pharmaceuticals and that depends Department of Health and Human Services U.S. - and as such comparable and compatible.

Let us briefly analyze the CEI EN 60601-1-2: 2007, we see how this will turn directly to the manufacturer of the device for what concerns the electromagnetic immunity, specifying the obligation on its part to provide the documents accompanying the levels Immunity; also certify the electromagnetic immunity of the device, among other things, the rule clarifies that there is a responsibility shared between the manufacturer, the organization responsible for the device and healthcare professionals for use in medical technology a secure environment and compatible.

As for immunity levels reported by the manufacturer, they can be equal to or greater than the minimum set by the harmonized standard, or even below the minimum levels provided there is a technical explanation and this is stated in the document to be included among those in support the device. The manufacturer must also attach news of the minimum separation distances between mobile RF transmitters and the medical device, calculated levels of immunity of the latter and the power and the frequency of the work of the portable communication system RF.

Just to give some examples, based on 'application of relevant legislation, in particular cases, in the circumstance of low power transmissions (10 maw) this device must be placed at a distance of at least 20 cm from mobile phones and / or UMTS, and Wife devices portable also, more generally, on the basis of experiments carried with the competent bodies, we can say that the remoteness of safety equipment, life support apply to all other devices.

However, there may be cases where some wireless technologies using frequency bands not already considered by regulations or rules are not known yet where the minimum safe distances. In such cases there are specific tests which the health facility can help them in assessing risk on electromagnetic interference (this can be established through the service of clinical engineering at the hospital in collaboration with the health department: it falls on them responsibility to ensure an ad hoc network).

By: Manuela Zazzara